tbuckley/cabot-search huggingface dataset:
Influence of follow-up time on outcome of children and adolescents with atypical Spitz tumor/Spitz melanoma (AST/SM): Results from the MACMEL registry.
Authors: Marija Kacar, Xiaomeng Yuan, Haitao Pan, Valerie McPherson, Alberto S. Pappo
Journal: Journal of Clinical Oncology (2023)

e21558 Background: Pediatric melanoma is a rare and challenging diagnosis, requiring an integrated clinicopathologic and genomic approach to optimize diagnosis and clinical care. The Molecular Analysis of Childhood Melanocytic Tumors (MACMEL) registry (Pappo A Cancer. 2021 Oct 15;127(20):3825-3831) was developed to better characterize pediatric melanocytic lesions by including clinical information, central pathology review, and genomic analysis. The AST/SM subtype of melanocytic lesions often affects younger patients, have a high incidence of nodal involvement, and are genomically characterized by copy number aberrations and kinase fusions. Methods: A review of the MACMEL registry data for patients with AST/SM enrolled from May 2016 to December 2022. Patient data included demographics (age, sex, ethnicity), anatomic location of lesion, sentinel node involvement, AJCC staging, genomic and germline findings, therapy, and disease outcomes. Results: We identified 60 patients with AST (n=17) and SM (n=43). 28 patients had stage III disease and 16 had stage IIIC disease. There were 38 females, and 22 males. The most common primary sites were the extremities and the most common gene rearrangements included MAP3K8 (n= 10) and ALK (n= 12). Other genomic alterations identified included kinase fusions NTRK, ROS1, BRAF, FLOT2-ARAF, RAC1, BRIP1, SDHAF2, ATM, GPNMB-ERBB2, and CDKN2B. None of the 55 patients that underwent TERT promoter analysis had a mutation. Adjuvant treatment was given to 8 patients (interferon 3, pembrolizumab 4, larotrectinib 1). The median follow-up time for the cohort is 3.1 years, with 57 patients alive with no evidence of disease. 1 patient had a local relapse treated with wide local excision and is currently alive with no evidence of disease. 3 patients were lost to follow up. Event free survival (EFS) for the cohort is 98% and overall survival (OS) is 100%. Conclusions: Patients with AST/SM comprise the largest subtype of melanocytic lesions enrolled on the MACMEL registry and have an excellent clinical outcome. This supports our previous observations that patients with AST/SM who lack TERT promoter mutations may be able to be managed conservatively and that an integrated diagnostic approach incorporating genomic information is vital for optimal diagnosis and clinical management. [Table: see text]
The impact of COVID-19 on the survival outcome of lung cancer at a Canadian academic centre: A real-world data analysis.
Authors: Jason S. Agulnik, Goulnar Kasymjanova, Carmela Pepe, Jennifer Friedmann, David I. Small, Lama Sakr, Hangjun Wang, Alan Spatz, Victor Cohen
Journal: Journal of Clinical Oncology (2023)

e21200 Background: The Covid-19 pandemic directly affected the screening, diagnosis, and treatment of lung cancer patients. Our group recently reported that the rate of new lung cancer diagnoses declined during the first year and significantly increased during the second of COVID-19 pandemic. The effect of COVID-19 on lung cancer treatment outcomes in literature is still limited and mostly reported either as predictive survival using prioritization and modeling techniques. In this study, we aimed to quantify the effect of COVID-19 on lung cancer survival using real world data collected at the Jewish General Hospital, Montreal. Methods: This is a retrospective chart review study including patients diagnosed with lung cancer between March 2019 and March 2022. We compared 3 cohorts: Cohort1: 2019 (pre-COVID) Cohort2: 2020 (1 st year of COVID) Cohort3: 2021 (2 nd year of COVID). Results: A total of 417 patients were diagnosed and treated with lung cancer at our centre throughout the three-year study: 130 in 2019, 103 in 2020 and 184 in 2021. Although the proportion of advanced/metastatic stage lung cancer remained the same for the three cohorts, there was a significant increase in the late-stage presentation during the pandemic. The proportion of M1c (multiple extrathoracic sites) cases in Cohorts 2 and 3 was 57% and 51% respectively compared to 31% in cohort 1 (p &lt; 0.05). Median survival for early and locally advanced stages of lung cancer was similar in the 3 cohorts. However, the subgroup of patients diagnosed in the advanced/metastatic stage had a significantly increased risk of death during the pandemic (cohorts 2 and 3). The 6-month mortality rate was 53% in 2021 compared to 47% in 2020 and 29% in 2019 (p = 0.004). The median survival in this subgroup of patients decreased significantly from 13 months in 2019 to 6 months in 2020 and 5 months in 2021 (Table 1). Conclusions: The present study represents the impacts of the COVID-19 on lung cancer survival outcome. The COVID-19 pandemic potentially caused the significant shift to M1c stage and contributed to an increase 6 month mortality rate and poorer overall survival in the advanced/metastatic lung cancer patients diagnosed and treated during the pandemic.[Table: see text]
Safety of same day administration of pegfilgrastim in breast cancer patients.
Authors: Kathryn Reynolds, Julia Katz, Lisle Nabell, Stefan C. Grant
Journal: Journal of Clinical Oncology (2023)

e18850 Background: Myelosuppressive therapy plays a crucial role in the treatment plan of patients with cancer; one common toxicity associated with myelosuppressive regimens is neutropenic fever. Pegfilgrastim is approved for use no sooner than 24 hours after receiving cytotoxic therapy, based on the initial FDA indication, requiring a return to clinic or the use of a patented on-body injector placed at the time of treatment. However, alternative schedules assessing earlier administration were never examined in the FDA registration studies. Small studies have suggested that same-day administration of pegfilgrastim can be carried out safely, including a prior safety study at UAB. The present analysis sought to test the non-inferiority of same day pegfilgrastim compared to administration 24-72 hours after cytotoxic chemotherapy. Methods: We undertook a retrospective analysis of 241 breast cancer patients receiving cytotoxic therapy from May 2016 through October 2018. The patient population was predominately Caucasian women with 28% African American or Asian women, and a median age of 55 (33-81). I2B2 codes identified patients with breast cancer receiving adjuvant or neoadjuvant therapy patients receiving same day versus next day pegfilgrastim were compared. Blood counts, delays in therapy, and neutropenic hospitalizations were analyzed for same day versus 24-hour delayed pegfilgrastim at two separate institutions. Dose reduced metastatic regimens were excluded from this review. Results: We comparedthe rate of neutropenia resulting in dose-delay for breast cancer patients receiving standard chemotherapy with administration of pegfilgrastim on both schedules. Overall, neutropenia with fever resulting in delay of subsequent chemotherapy was similar in both groups with same day administration being non-inferior to the standard administration schedule. Other treatment delays due to non-neutropenic conditions included mucositis, port malfunction, COPD, fatigue, and transportation delays. Conclusions: Policies requiring 24-hour delays following chemotherapy for pegfilgrastrim administration, reduce utilization of biosimilars and make the on-body injector, Onpro, a more convenient, albeit expensive option, for patients and the health system. These data suggest that same day administration of pegfilgastrim are non-inferior to delayed administration and may provide both substantial cost savings and quality of life benefits to patients and health care systems by increasing utilization of biosimilars and removing the need for a return visit after chemotherapy. In addition, same day administration also reduces the risk of complications associated with on body injector use, where failure rates of up to 10% are reported.
Tumor volume and T2 hyperintensity changes from DeFi: A phase 3, randomized, controlled trial of nirogacestat in patients with desmoid tumors.
Authors: Thierry Alcindor, Bernd Kasper, Mrinal M. Gounder, Ravin Ratan, Winette T.A. Van Der Graaf, Breelyn A. Wilky, Richard F. Riedel, Noah Federman, Agnese Peruzzi, Stephanie Moody, Allison Lim, Brad Tumminello, Shivaani Kummar, Patrick Schöffski
Journal: Journal of Clinical Oncology (2023)

11514 Background: MRI tumor volume or T2 signal intensity changes may represent novel imaging techniques that could have a prognostic or predictive value for assessing response in desmoid tumors (DT). For example, hyperintense areas on T2-weighted images have been associated with active fibroblastic proliferation and ≥90% hyperintensity is associated with DT disease progression, whereas iso- or hypo-intense areas are associated with inactive sites of disease. In DeFi (NCT03785964), the novel gamma secretase inhibitor nirogacestat (n=70 patients) significantly improved the primary endpoint of PFS compared with placebo (n=72 patients; hazard ratio, 0.29 [95% CI, 0.15, 0.55; P&lt;0.001]) and significantly improved the secondary endpoint of ORR per blinded, independent central review (41% vs 8%; P&lt;0.001). Complete responses were achieved in 7% with nirogacestat and 0% with placebo. Here, we present an exploratory analysis of MRI tumor volume and T2 signal intensity changes in DeFi. Methods: Eligible adults had histologically confirmed DT that had progressed ≥20% per RECIST v1.1 within 12 months of screening. Patients were randomized 1:1 to receive nirogacestat 150 mg or placebo twice daily taken continuously in 28-day cycles. Volumetric MRI and T2 hyperintensity of the largest target tumor were evaluated at screening and every 6 cycles during the double-blind phase. MRI T2 signal intensity is represented as the ratio of hyperintensity in total tumor volume to muscle background. A blinded, independent, central radiologist reviewed all MRI scans. Results: Nirogacestat treatment led to more substantial reductions versus placebo in tumor volume and T2 hyperintensity ratio (Table). At baseline, similar proportions of patients in each arm had a T2 hyperintensity ratio ≥90% (95% vs 97%). This ratio changed from ≥90% at baseline to &lt;90% at any time after baseline in 34% of patients in the nirogacestat arm and 15% of those on placebo. Conclusions: In DeFi, nirogacestat demonstrated substantial reduction of tumor volume and T2 hyperintensity of the largest target tumors by MRI compared with placebo in adults with DT. These results are consistent with the significant improvement in ORR achieved with nirogacestat. These data suggest that volumetric MRI and T2 hyperintensity might provide additional information in the evaluation of treatment response in DT. The prognostic or predictive value of these imaging techniques in DT should be further studied. Clinical trial information: NCT03785964 . [Table: see text]
Real-world assessment of treatment effectiveness in patients with advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping (METex14).
Authors: Muhammad Furqan, Siddharth Karanth, Ravi K. Goyal, Yu-Hsuan Shih, Beilei Cai, Julien Rombi, Keith L. Davis, Nydia Caro, Teddy Rassem Saliba
Journal: Journal of Clinical Oncology (2023)

e21112 Background: Capmatinib is approved for patients (pts) with advanced stage (a)NSCLC harboring METex14. However, there is limited data on capmatinib activity in comparison to other approved therapies. We assessed real-world (rw) clinical outcomes of pts with aNSCLC with METex14 who initiated treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) regimens. Methods: In a retrospective chart review, data were abstracted by a sample of oncologists invited nation-wide in the US who randomly selected prespecified numbers of charts, with larger sampling targets for capmatinib and IO therapies. Eligible pts were aged ≥18 years, had stage ≥IIIB NSCLC and METex14; received first-line (1L) systemic therapy after 1 January 2017 with follow up of ≥6 months after starting 1L therapy (except death) as of the data abstraction date; and did not receive MET inhibitors other than capmatinib. Clinical outcomes included best overall real world response rate (rwORR), progression-free survival (rwPFS), overall survival (OS), and time to treatment discontinuation (TTD). RwORR was assessed using rw-RECIST guided by RECIST 1.1 criteria or physician documentation. All measures were descriptively analyzed. Time-to-event outcomes were assessed per line of therapy via Kaplan-Meier methods. Results: In total, 287 eligible pts were identified. Median age was 63.3 years, 71% were male, 41% were non-White, and 49.5% were treated in community settings. 15 pts had brain metastasis at diagnosis. Pts who received 1L capmatinib had higher rwORR and longer rwPFS, OS, and TTD than pts who received 1L IO mono or CT alone or in combination (Table 1). Pts treated with second-line (2L) capmatinib had higher rwORR than other treatments but was a smaller pt population. Conclusions: Our analysis suggests that capmatinib in aNSCLC with METex14 yields numerically better clinical outcomes than IO or CT alone or in combination. These findings support use of capmatinib in this setting and may inform clinical decision making in routine practice. [Table: see text]
Effects of a focused one-day interactive session on oncology research on medical students’ interest in and understanding of oncology research.
Authors: Jawad Alrawabdeh, Marah Alzubi, Nada Wael Odeh, Yazan Hamadneh, Mahmoud Odeh, Enas Yousef Khasawneh, Abdallah Al-Ani, Muhammad Hammouri, Mamoun Ahram, Abdalla Abbadi
Journal: Journal of Clinical Oncology (2023)

11037 Background: Literacy and proficiency in medical research are crucial for the development of modern-day physicians. The need to equip future doctors with sufficient research skills is particularly important in oncology research, as cancer is the second leading cause of death in Jordan and the first worldwide. With the support of the University of Jordan ASCO-OSIG, we explored the efficacy of an interactive research intervention in highlighting the foundations of cancer clinical, basic, and translational research among undergraduate medical students. Methods: We designed and implemented a one-day educational program about all types of cancer research: clinical, basic, and translational. To evaluate the impact of this ASCO-OSIG initiative, students were asked to voluntarily fill surveys before and after the event. Medical students in both their pre-clinical and clinical training were invited to attend the event. Prominent researchers and experts from multiple tertiary cancer centers in Jordan presented 50min lectures on the foundations of clinical, basic, and translational oncology research. Results: A total of 111 participants filled the pre and post surveys, of which ASCO-OSIG members comprised 28.8% of the sample. Approximately 51.4% of participants were pre-clinical students and 48.2% were in their clinical years. About half of our cohort (50.2%) have previously engaged in research projects with only 10.2% of participants have been involved in oncology research. The event was effective in promoting participants’ understanding and familiarity of the fundamentals of clinical (p-value &lt; 0.001), translational (p-value &lt; 0.001), and basic oncology research (p-value &lt; 0.001). Most students were satisfied with the event; with 55% and 32.4% of students reporting being very satisfied and extremely satisfied with the event, respectively. Moreover, 83.8% of participants felt that oncology research was easier to get into after the event. About 96% of students reported that they would recommend this event to a colleague. Conclusions: We demonstrated that a focused one-day cancer research conference had improved medical students’ understanding towards oncology research. Due to its design simplicity, other global ASCO-OSIG coordinators could implement the model within their respective institutions. Future efforts should expand on the available research initiatives and include other medical schools worldwide.
Timeliness of care for breast cancer patients with a single day multidisciplinary clinic.
Authors: Lindsey Leigh Farmer, John Allen Terrell, David Luis Ramirez
Journal: Journal of Clinical Oncology (2023)

e18750 Background: Single-day multidisciplinary cancer clinics began in the 1960s, but have been difficult to institutionalize due to a lack of literature demonstrating the benefits for patients and the high cost of implementation1. Other institutions have shown that patients are seen by specialists sooner, receive treatment earlier, and have reduced stress when care is delivered in this model 1-6. MDA sought to improve breast cancer patient’s access by implementing a single-day multidisciplinary clinic in 2013. Methods: We identified local patients (within 150 miles) who were treated at MD Anderson Cancer Center Main for breast cancer from March 2016 to March 2022. Patients were either seen in the single-day multiteam (MT) model (Table 1) with coordination between surgical oncology, radiation oncology, and medical oncology or by specialists in the traditional model. Time from referral to first completed provider appointment was analyzed. Results: A total of 4,999 patient records were reviewed. 2,288 were seen in MT and 2,711 were seen in the traditional model. Median number of work days from referral to first appointment completion was 8 days vs 14 days respectively (p-value &lt; 0.0001). Conclusions: A single-day MT visit is associated with reduced time from referral to first appointment completion. Further studies are warranted to determine if this shorter interval can improve patient outcomes and experience. Multiteam Protocol Plan Time frame Prior to clinic visit Nurse Patient Access Coordinator obtains pertinent medical information for initial encounter Multiple days prior to visit Clinic Day PA meets with patient to perform H&amp;P, review acquired imaging and pathology, describe multiteam goals, and briefly discuss treatment options 11:00-11:30 PA presents patient cases to surgical oncologist, medical oncologist, and radiation oncologist. Treatment options are discussed. 2:00-2:30 Entire team meets the patient and performs an exam. 2:30 Encounter with medical oncology to discuss systemic treatment options. 2:45 Encounter with surgical oncology to discuss surgical treatment options. If necessary, patient consents for surgery. 3:15 Encounter with radiation oncology to discuss radiation therapy. 3:45 Nurse wraps clinic day with necessary patient teaching and assistance with scheduling any required further work up. 4:15.
Exploring the benefits of therapeutic horticulture in patients in gynecologic oncology: A pilot study.
Authors: Vasanti Jhaveri, Leah Diehl, Alexis Jennings-Coulibaly, Derek Li, Patricia Durning, Shazia Bashir, Merry Jennifer Markham, Alice Rhoton-Vlasak
Journal: Journal of Clinical Oncology (2023)

e24038 Background: Women who are diagnosed with gynecologic cancer experience a significant level of distress and symptoms that impact their quality of life. Recently, there has been an emphasis on quality of life for oncology patients. Non-pharmacological interventions such as therapeutic horticulture (TH) have been linked with enriching individual lives. TH is defined as the engagement of a person in gardening and plant-based activities, facilitated by a professionally registered horticultural therapist, to achieve specific treatment goals. The purpose this study is two-fold: 1) to determine the impact of TH on quality of life and anxiety for gynecologic oncology patients and 2) to test the feasibility and acceptability of implementing a pilot TH program for this specific patient population. Methods: This was an IRB approved study. Individuals were recruited from the oncology clinic. Inclusion criteria included adult women, age 18 and over, who were diagnosed with gynecologic cancer. They were included in the study independent of what stage they were in their cancer treatment. The intervention included attending eight 1-hour group-based gardening sessions that were led by a professionally registered horticultural therapist at Wilmot Botanical Gardens. Self-report psychometric assessments were administered to assess anxiety and quality of life before and after the intervention. Results: Over one month, ten patients were interested in the study. Due to limitations in funding, only seven were able to partake in the study. Three participants were able to complete the study in its entirety by attending eight out of the twelve sessions. Four participants were unable to complete at least eight sessions due to scheduling conflicts: one completed seven sessions and three completed less than five sessions. Given that only three patients completed the intervention, quantitative measures are not included. In the focus group at the end of the study, the three participants described the TH as engaging and felt that they were more physically active and mentally at peace. They felt that the sessions brought camaraderie amongst each other regardless of the number of sessions attended. Conclusions: While our participant accrual was limited, the study was noted to be feasible and acceptable with the sessions being overall helpful for well-being. Given the results from this study, more funding has been established for recruiting a larger cohort in Fall of 2023.
Famitinib for familial adenomatous polyposis-associated aggressive desmoid tumors: A single-center exploratory study.
Authors: Sai Ge, Jian Li, Lin Shen, Zhenghang Wang, Huajun Li, Xicheng Wang
Journal: Journal of Clinical Oncology (2023)

10513 Background: Desmoid tumour (DT) is a common extra-intestinal manifestation of familial adenomatosis polyposis (FAP), with high risk of recurrence and became the second leading cause of FAP patients’ death. The treatment of FAP-associated DTs are limited. Famitinib is a orally bioavailable, tyrosine kinase inhibitor against VEGFR-2, PDGFR, c-kit, and FGFR, and has shown antitumor activity in these patients (pts). Methods: This is a prospective, single arm study of FAP pts with progressing DT per RECIST v1.1, treated with famitinib 20 mg QD since 11/2021. The primary endpoint was objective response rate (ORR), with secondary endpoints of safety, progression-free survival (PFS), and quality of life (EORTC QLQ C30). We also collected the FFPE slices of DTs to test both genetic and proteomic backgrounds of pts with different therapeutic results. Results: Between Nov 24, 2021 and Aug 8, 2022, 11 pts were enrolled and evaluated every 9 weeks. The median follow-up time was 9.4 m (6.6 to 14.9 m). The median age was 36 (28-53) and 45% were male. Nine pts were diagnosed with intra-abdominal (IA) tumors while two had extra-abdominal (EA) DTs. Eight had stage III-IV DTs with rapid growth and severe symptoms. 10 of them had history of intestinal resection. Two pts were treated with dacarbazine and epirubicin before enrollment, while one patient received radiotherapy before famitinib. Five pts achieved partial response (PR) and six achieved stable disease (SD), with a median time to response of 7.0 months. The ORR was 45.5% and the disease control rate (DCR) was 100%. The 6-month PFS rate was 91%. The ORR of pts with IA DTs was 55.6%. Of adverse events (AEs) with famitinib, 87% were grade 1/2, the most frequently reported being hypertension (73%), neutropenia (64%), bilirubinemia (55%) and proteinuria (36%). Mean global health status/QoL before and after 6 months’ treatment was 58.3 vs 75.8 ( P= 0.09). Of all 11 pts, germline APC mutations scattered from codon 457 to 1578, and five of them detected somatic APC mutations from codon 547 to 1896 in DTs. Correlative study analysis will be presented. Conclusions: Famitinib demonstrated promising efficacy and a favorable safety profile in FAP-associated aggressive DTs.